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The goal of this clinical trial is to develop a new behavioral treatment for U.S. combat veterans with post-traumatic stress disorder (PTSD), very brief exposure to combat-related stimuli. The main questions it aims to answer are:
All participants will view both very brief exposure and visible exposure to combat stimuli in the functional magnetic brain imaging (fMRI) scan. They will provide ratings of fear, awareness, and tolerability. Researchers will compare U.S. combat veterans with PTSD and healthy controls to confirm differences in brain region activation and ratings.
The prevailing treatment for Post-traumatic Stress Disorder (PTSD) is exposure: the confrontation of traumatic memories, in one form or another. Although exposure therapies are effective for combat related PTSD, confronting traumatic memories is inherently aversive, which may contribute to problems with patient acceptance. For example, trauma-focused PTSD therapies have higher dropout rates than non-trauma-focused therapies, and combat vets who drop out in real-world practice have more avoidance behaviors and greater arousal than those who remain in treatment. Study investigators have developed an alternative form of exposure that has been repeatedly shown to reduce behavioral, physiological, and self-reported fear symptoms in phobic persons without having them directly confront feared situations, and thus without causing them to experience emotional distress. In Very Brief Exposure (VBE), a series of pictures representing a person's fears (e.g., a combat scene with arousing visuals) is presented very briefly (17 ms), followed by a masking stimulus that prevents conscious recognition of each picture. This sequence of picture-mask stimuli is repeated many times in an exposure session.
The goal is to develop a new behavioral treatment for U.S. combat veterans with PTSD, VBE to combat-related stimuli by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image Exposure Arm | Experimental | This within-subjects design study will have all participants view three types of exposure during fMRI scanning: VBE to combat images, VBE to masked everyday scenes (control), and conscious visible exposure to the same images (control). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Brief Exposure to Combat Images | Other | In VBE, a series of pictures representing a person's fears (e.g., a combat scene with arousing visuals) is presented very briefly (17 ms), followed by a masking stimulus that prevents conscious recognition of each picture. This sequence of picture-mask stimuli is repeated many times in an exposure session. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Activation of Frontostriatal and Prefrontal Brain Regions to combat stimuli in PTSD | A hypothesis-driven, group-level analysis will test brain activity, measured as Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest while minimizing Type II error. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Fear induced by exposure to combat stimuli in PTSD in veteran group as measured by fear scale | After each block of 10 combat stimuli trials, participants rate levels of fear on a 10-point, 1-10 visual analogue scale with these anchor point: "1 - No fear", "5 - Moderate but Tolerable Fear", and "10 - Very Intense Fear". | Day 2 |
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Inclusion Criteria:
Patient Population
Healthy Population
• Males and Females, ages 18-50
Exclusion Criteria:
Patient Population
Healthy Population
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Marcelino | Contact | 323-361-6456 | cmarcelino@chla.usc.edu | |
| Bradley S Peterson, MD | Contact | 323-361-3654 | bpeterson@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bradley M Peterson, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Imaging Lab | Recruiting | Los Angeles | California | 90027 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 11, 2023 | Jan 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
| Fear induced by exposure to combat stimuli in PTSD in healthy participants as measured by fear scale |
After each block of 10 combat stimuli trials, participants rate levels of fear on a 10-point, 1-10 visual analogue scale with these anchor point: "1 - No fear", "5 - Moderate but Tolerable Fear", and "10 - Very Intense Fear". |
| Day 2 |
| Fear induced by exposure to combat stimuli in PTSD in veteran group as measured by fear scale | After each block of 10 combat stimuli trials, participants rate levels of fear on a 10-point, 1-10 visual analogue scale with these anchor point: "1 - No fear", "5 - Moderate but Tolerable Fear", and "10 - Very Intense Fear". | Days 3-7 |